BEACON

• Research type

  Research Study

• Full title

  Boosting Exercise cApaCity with autOnomic Neuromodulation

• IRAS ID

  299987

• Contact name

  Gareth Ackland

• Contact email

  g.ackland@qmul.ac.uk

• Sponsor organisation

  Joint Research Management Office, Queen Mary University of London

• Duration of Study in the UK

  0 years, 6 months, 1 days

• Research summary

  There is loss of function in a nerve called the vagus nerve during major surgery. Loss of function in the vagus nerve is associated with increased risk of complications and death after surgery. The mechanisms resulting in loss of function in the vagus nerve require greater exploration, in order to develop strategies to improve outcomes following major surgery.
  The vagus nerve protects the heart and other vital organs, by feeding back information to the brain, and subsequently mounting a protective response. Patient studies suggest that loss of function in the vagus nerve is also a feature of inability to exercise, which is key to recovery from surgery. We aim to identify potential benefits of a device to maintain/boost function of the vagus nerve and ability to exercise in human volunteers, to prove this treatment may safely benefit patients undergoing major surgery in future studies.
  We will test function of the vagus nerve by activating a particular nerve reflex, which involves 30 minutes daily (i) stimulation of a battery-operated portable device attached to patients’ outer ears or (ii) no stimulation. Participants shall be randomly assigned to one of these two intervention groups.
  The intervention will be performed daily for 7 consecutive days. After a 14 day break, participants will take 7 consecutive days of the opposite intervention. An exercise bike test, markers of function of the vagus nerve (ECG-recorded heart rate changes and a sitting-to-standing test) and a blood test will be taken on days 1 and 7 of each week of the interventions; these outcome measures shall be compared between the two intervention groups. Participants will perform the exercise bike and sitting-to-standing tests whilst recording an ECG, in which wires monitoring the heart will be attached on the chest. The study shall be completed in 6 months.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  21/LO/0856

• Date of REC Opinion

  22 Dec 2021

• REC opinion

  Further Information Favourable Opinion